Accuracy and Predictive Values for Colorectal Cancer of Quantitative FIT in Symptomatic Patients in Primary Care

Colorectal Cancer Clinical Trial

Official title:

Accuracy and Predictive Values for Colorectal Cancer of a Quantitative Faecal Immunochemical Test in Symptomatic Patients in Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05156307
• Other study ID #: 275691
• Status: Recruiting
• Start date: May 20, 2021
• Est. completion date: June 2024

Study information

• Verified date: November 2021
• Source: Region Örebro County
• Contact: Anna Lööv, MD
• Phone: +46735454965
• Email: anna.loov[@]regionorebrolan.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to determine accuracy and predictive values for colorectal cancer of a faecal quantitative immunochemical test (FIT) in unselected symptomatic patients presenting in primary care. Main reference test will be linkage to a nationwide colorectal cancer registry.

Description:

This is a nationwide multi-centre study in primary care, Sweden. Patients from the age of 40 years and above presenting in primary care with symptoms associated with colorectal cancer prompting their GP to take actions are eligible. Consenting patients will fill out a short form on symptoms during last 4 weeks. They will provide 2 faecal samples from 2 different days. Samples will be analysed at any of three laboratories within 5 days using QuikRead go® (Aidian Oy). The analytical working range is 10-200 µg Hb/g faeces. The outcome will be reported as the concentration of first test (FIT 1) and highest concentration of two tests (FIT max). The outcome of the study FIT will remain within the study and GPs must request a separate FOBT for clinical purposes. Reference test will be linkage to the Swedish Colorectal Cancer Registry (with in practice complete coverage) after at most 2 years for all patients. Accuracy and predictive values will be determined and ROC-curves analysed. Some patients included in the study will be referred for colonoscopy for clinical reasons, and the outcome of FIT in relation to colonoscopy findings will be reported for this group as well.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: June 2024
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

Patients presenting in primary care with symptoms associated with colorectal cancer prompting their GP to take actions are eligible. Exclusion Criteria: Referral for bowel examination for other reasons than symptoms. Not able to understand the instructions for participation.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Sweden	Skebäcks VC	Örebro

Sponsors (6)

Lead Sponsor	Collaborator
Region Örebro County	Dalarna County Council, Sweden, Landstinget i Värmland, Region Jämtland Härjedalen, Region Östergötland, Uppsala County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colorectal cancer	Linkage to cancer registry	2 years